Responsive Neurostimulation For Loss Of Control Eating (DBSLOC)

• ClinicalTrials.gov Identifier: NCT03868670
• Recruitment Status: Recruiting
• First Posted: March 11, 2019
• Last Update Posted: March 11, 2019
• Sponsor: Casey H. Halpern
• Collaborator: NeuroPace
• Information provided by (Responsible Party): Casey H. Halpern, Stanford University

Tracking Information

• First Submitted Date: February 14, 2019
• First Posted Date: March 11, 2019
• Last Update Posted Date: March 11, 2019
• Estimated Study Start Date: February 27, 2019
• Estimated Primary Completion Date: January 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2019)

• Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability] [ Time Frame: 5 years ]
  Safety of the RNS System and NAc stimulation through evaluation of AE's graded as "related" (vs. not related) to the intervention that will be graded based on severity. Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
• Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week [ Time Frame: 5 years ]
  This endpoint will be met if at least 50% of subjects exhibiting a decrease in the number of Loss of Control (LOC) episodes per week. LOC episodes will be assessed by the currently available standard, ecological momentary assessment (EMA) diary entries.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Responsive Neurostimulation For Loss Of Control Eating
• Official Title: Responsive Neurostimulation For Loss Of Control Eating
• Brief Summary: The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.
• Detailed Description: This is a single site, early feasibility study to support development of a novel therapeutic approach for utilizing the NeuroPace RNS® System for nucleus accumbens responsive neurostimulation (NAc- RNS) to ameliorate loss of control over (LOC) eating in persons with treatment-refractory obesity, specifically those who have failed gastric bypass surgery. The primary objectives are to assess the safety & feasibility & potential efficacy of the medical device named the NeuroPace RNS® System
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility

Condition

• Loss of Control Eating
• Obesity, Morbid

Intervention

Device: responsive neurostimulation

The RNS® System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to continuously monitor brain electrical activity, detect abnormal electrical activity and respond by delivering imperceptible levels of electrical stimulation to normalize that activity before an individual experiences seizures. This is an Early Feasibility Study determining the safety and efficacy of NAc-RNS in the treatment of LOC eating in treatment-refractory obesity.

Study Arms

Experimental: Responsive Neurostimulation

Surgical arm. Patients expected to receive treatment.

Intervention: Device: responsive neurostimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 6, 2019): 6
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2025
• Estimated Primary Completion Date: January 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• BMI 45-60 kg/m2
• Failure of at least one weight loss medication
• Previous Gastric Bypass Surgery lead to less than 50% of excess weight lost by 2 years after surgery
• Significant Loss of Control over eating
• Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
• Premenopausal women must agree to use acceptable methods of birth control.
• Participants provide voluntary, decisionally capable, and appropriately informed consent.
• Subject is able to comply w/ all testing and follow-up requirements defined by the study protocol.
• Participant has no immediate plan for relocation beyond 6 hours of the study site.
• Proficiency with the English language.

Exclusion Criteria:

• Subject has an implanted medical device that delivers electrical energy to the brain.
• Subject has an implantable cardiac pacemaker, defibrillator, or neurostimulator.
• Subject is likely to require repeat MR imaging after implant of the RNS Neurostimulator and Leads.
• Subject is unable to fit into CT scanner (500lb upper weight limit for CT scanner).
• Inability to provide informed consent to treatment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Vyvian Ngo, BS, MPH; 650-498-0817; vyviann@stanford.edu

Contact: Emma Adair, BS; eadair@stanford.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03868670
• Other Study ID Numbers: IRB-46563
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Casey H. Halpern, Stanford University
• Study Sponsor: Casey H. Halpern
• Collaborators: NeuroPace
• Investigators: Not Provided
• PRS Account: Stanford University
• Verification Date: March 2019